?d T-PD-1 Ab Cells in the Treatment of Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor

• Registration Number: NCT06404281
• Lead Sponsor: Changzhou No.2 People's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-4-21
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Inclusion Criteria:<br><br> 1. The patient voluntarily signs the informed consent and can complete the follow-up<br> examination, evaluation and treatment;<br><br> 2. Age 18-80 years old, gender is not limited;<br><br> 3. The histopathological diagnosis was malignant solid tumor;<br><br> 4. Clinical or pathological was stage IV according to AJCC 8th edition stage;<br><br> 5. Subjects with advanced solid tumors without standard treatment options;<br><br> 6. ECOG score 0-1;<br><br> 7. Expected survival =6 months;<br><br> 8. Have at least one evaluable lesion according to RECIST 1.1 criteria;<br><br> 9. Organ function level requirements (no blood transfusion or blood products, no<br> hematopoietic stimulating factors, no albumin or blood products used within 14 days<br> prior to the first dose);<br><br> 10. Bone marrow function: absolute value of neutrophils (ANC) =1.5×109, platelets<br> =75×109, and hemoglobin (Hb) =90g/L;<br><br> 11. Liver function: total bilirubin =1.5 times the upper limit of normal (ULN);<br> Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 times ULN<br> (5.0 times ULN if liver metastasis is present), alkaline phosphatase < 5 × ULN;<br><br> 12. Renal function: serum creatinine level =2 ULN, creatinine clearance > 50mL/min<br> (according to Cockcroft-Gault formula); Urine protein <2+(If urine protein =2+,<br> urine protein measurement should be collected for 24 hours, and the total amount<br> should be <1g to be allowed to enter the group);<br><br> 13. The serum pregnancy test of women of childbearing age in the 7 days prior to<br> Gamma-delta T-PD-1 Ab infusion is negative, and any fertile male and female subject<br> must consent to the use of an effective contraceptive method throughout the study<br> and for at least 12 weeks after the last study administration. In the researchers'<br> judgment, a subject is fertile: he/she is biologically capable of having children<br> and having a normal sex life.<br><br> 14. A hysterectomy or bilateral oophorectomy has been performed, or ovarian failure has<br> been medically confirmed, or post-menopause has been medically confirmed (menopause<br> for at least 12 consecutive months without pathological or physiological causes).<br><br>Exclusion Criteria:<br><br> 1. Intolerance or allergy to any ingredient or similar drug in the treatment plan<br> planned for this study;<br><br> 2. Metastasis of symptomatic central system;<br><br> 3. Have received other cell therapies, including NK, CIK, DC, CTL, CAR-T, TCR-T, and<br> stem cell therapy in the past 4 weeks;<br><br> 4. Received systemic steroid therapy (> 10 mg/kg prednisone or equivalent) or any other<br> form of immunosuppressive medication within two weeks prior to the first dose;<br> Corticosteroids (=10mg oral prednisone or equivalent) were used in subjects with<br> chronic obstructive pulmonary disease, saline corticosteroids (such as<br> hydrohydrocortisone) were used in subjects with postural hypotension, and low-dose<br> supplemental corticosteroids were used in subjects with adrenal insufficiency.<br><br> 5. Plan to use any other form of systemic antitumor therapy during the study period;<br><br> 6. History of known hematological malignancy, primary brain tumor or sarcoma, or other<br> primary solid tumor within 6.5 years, unless cured and no evidence of recurrence of<br> the disease within 5 years. With the exception of cured basal cell carcinoma of the<br> skin and cervical carcinoma in situ;<br><br> 7. History of interstitial lung disease, non-infectious pneumonia or uncontrolled<br> disease, including pulmonary fibrosis and acute lung disease;<br><br> 8. Active autoimmune diseases within the past 2 years requiring systemic treatment<br> (such as glucocorticoids or immunosuppressive drugs), and related replacement<br> therapy (such as thyroxine, insulin, or physiologic glucocorticoid replacement<br> therapy for renal or pituitary insufficiency); Bisphosphonates were administered<br> within 2 months prior to Gd T-PD-1 Ab infusion.<br><br> 9. Known subjects had systemic vasculitis, co-active or uncontrolled autoimmune<br> disease, primary or secondary immune deficiency, graft-versus-host disease (GvHD).<br><br> 10. Hepatitis B infection, hepatitis C infection, human immunodeficiency virus (HIV)<br> infection, Treponema pallidum (TP) infection.<br><br> 11. Had undergone major surgery within 4 weeks prior to screening that was assessed by<br> the investigator as unsuitable for enrollment.<br><br> 12. Acute infection and gastrointestinal bleeding occurred in 4 weeks.<br><br> 13. Major organ dysfunction: absolute value of neutrophils (ANC) < 1.5×109, platelets <<br> 75×109, and hemoglobin (Hb) < 90g/L; Serum albumin < 28g/L, total bilirubin<br> >51µmol/L, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5<br> times the upper limit of normal, creatinine > 1.5 times the upper limit of normal;<br> Have abnormal coagulation function (INR > 1.5 or PT >1.2 ULN or PTT >1.2 ULN), have<br> a tendency to bleed, or are receiving thrombolytic or anticoagulant therapy.<br><br> 14. The subject's heart meets any of the following conditions: Left ventricular ejection<br> fraction (LVEF) =45%; New York Heart Association (NYHA) Class III or IV congestive<br> heart failure; QTcB > 450 msec; Other heart conditions that the investigators judged<br> unsuitable for inclusion.<br><br> 15. People with a history of epilepsy or other active central nervous system diseases.<br><br> 16. Received live vaccine within 6 weeks prior to screening, and received hematopoietic<br> stimulating factors, such as colony-stimulating factor and erythropoietin, within 2<br> weeks prior to treatment; Major surgical procedures (excluding diagnostic surgical<br> procedures) within 4 weeks before the start of treatment;<br><br> 17. Evidence of uncontrolled and severe active infection at the time of screening (e.g.,<br> sepsis, bacteremia, fungemia), or a recent (within 4 months) history of deep tissue<br> infection (e.g., fasciitis or osteomyelitis).<br><br> 18. Participate in other interventional clinical investigators within 3 months prior to<br> infusion of ?d T-PD-1 AB-PD-1 Ab.<br><br> 19. A known mental or substance abuse disorder may interfere with the requirement to<br> cooperate in the completion of the trial.<br><br> 20. Women who are pregnant or breastfeeding, or who plan to become pregnant or have<br> children during the study period.<br><br> 21. In the investigator's judgment, the subject has any serious acute or chronic<br> physical or mental illness, or laboratory abnormalities that could increase the risk<br> of study participation, study administration, or possibly affect the interpretation<br> of study results.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety evaluation: Incidence of Adverse events (AEs);Safety evaluation: Dose limited toxicity (DLTs);Safety evaluation: Maximum-tolerated dose (MTD)

Secondary Outcome Measures

Name	Time	Method
Efficacy evaluation: Objective Response Rate(ORR);Efficacy evaluation: Disease Control Rate (DCR);Efficacy evaluation: Progress Free Survival(PFS);Efficacy evaluation: Overall Survival (OS)